Antimicrobial Sanitizer Compositions and Their Use

ABSTRACT

The present invention relates to antimicrobial sanitizing compositions for use as skin sanitizers, especially sanitizers for the hands and feet, and air sanitizers and deodorisers. The sanitizing compositions comprise a combination of three ammonium compounds (ie. an alkoxy silyl ammonium compound, a benzalknonium chloride or benzethonium chloride and a polymeric biguanide) in a non-ionic surfactant carrier. The non-ionic surfactant system comprises an alcohol ethoxylate and an alkylglucoside or alkylpolyglycoside. Methods of use of the compositions are also described.

FIELD OF THE INVENTION

The present invention relates to antimicrobial sanitizing compositionsfor use as skin sanitizers, especially sanitizers for the hands andfeet, and air sanitizers and deodorisers. The sanitizing compositionscomprise a combination of three ammonium compounds in a non-ionicsurfactant carrier. Methods of use of the compositions are alsodescribed.

BACKGROUND OF THE INVENTION

Today in the age of advanced medical device technology and antibioticmedicines, the world is faced with hospitals and common facilities suchas schools and governmental agencies that have cultured antibioticresistant microorganisms. The Center for Disease Control (CDC) estimatesthat more than two million people are affected by antibiotic-resistantinfections every year in the United States, with at least 23,000 dyingas a result. Hospital nosocomial infections have generated the termsmethacillin resistant Staphylococcus aureus (MRSA), vancomycin resistantEnterococcus (VRE), carbapenem-resistant Enterobacteriaceae (CRE),multi-drug resistant tuberculosis (MRT TB) and Clostridium difficile (CDif) as a listing for infections caused by bacteria which have mutatedto become resistant to common antibiotics. While microorganisms aretransferred both by contact and aerosol, hand washing and effective handsanitization are visible means to reduce the spread of microorganisms,especially antibiotic resistant microorganisms.

Effective hand sanitizers are needed as a prophylactic measure forhealth care workers, patients and visitors to kill common germs on thehand's skin surface in medical facilities. According to Boyce J M, et alin Guideline for Hand Hygiene in Health-Care Settings “Hand hygiene isconsidered the most important measure for preventinghealth-care-associated infections and the spread of antimicrobialresistant pathogens.”

Health-care workers can also contaminate their hands with S. aureus,enterococci, or Clostridium difficile by doing clean procedures ortouching intact areas of skin of hospitalized patients. Studies haveestimated the frequency of health-care workers' glove contamination withMRSA after contact with a colonized patient. Health-care workers wereintercepted after a patient-care episode and cultures were taken fromtheir gloved hands before hand washing took place; 17% (95% CI 9-25) ofcontacts with patients, patient clothing, or patient beds resulted intransmission of MRSA from a patient to the health-care worker's gloves.

Alcohol hand sanitizers are effective on contact but after the alcoholevaporates there is no means to control microbial growth. Gelled alcoholsanitizers using hydroxyethyl cellulose or carbopols trap the dead cellsand bacteria on the surface of the skin after the alcohol hasevaporated. Alcohol hand sanitizers are also flammable resulting infires, in skin burns by accident and on purpose as acts of terror.Patient misuse of these products as intoxicants has been reported inprisons, emergency rooms, and medical units.

Furthermore, continued ethanol use in hand sanitisers causes skin damageand this is a problem for health-care workers that need to use alcoholbased hand-sanitizers on a regular basis. There is a need fornon-alcohol based hand sanitizers that are antimicrobially effective andlong lasting.

Advantageously, the present invention provides a sanitizing compositionfor skin and air that contains no alcohol, is antimicrobially effectiveon a wide range of microorganisms including Gram negative bacteria, Grampositive bacteria, viruses, fungi and protozoa, and has persistentand/or long lasting activity.

SUMMARY OF THE INVENTION

In a first aspect of the present invention there is provided asanitizing composition comprising:

-   -   i) an alkoxy silyl ammonium film-forming compound;    -   ii) a benzalkonium or benzethonium chloride;    -   iii) a polymeric biguanide; and    -   iv) a surfactant system comprising:        -   a) an alcohol ethoxylate; and        -   b) an alkylglucoside or alkylpolyglycoside.

In another aspect of the invention, there is provided a method ofsanitizing or disinfecting skin, especially hands or feet comprisingapplying to the skin of a subject, the hand-sanitizing composition ofthe present invention.

In a further aspect of the invention, there is provided a method oftreating or preventing a fungal infection of the skin, comprisingapplying the sanitizing composition of the invention to the skin of asubject.

In yet another aspect of the present invention, there is provided amethod of deodorising and/or sanitizing the air comprising dispersingthe composition according to the invention into the air.

DESCRIPTION OF THE INVENTION Sanitizing Compositions

In a first aspect of the present invention, there is provided asanitizing composition comprising:

-   -   i) an alkoxy silyl ammonium film-forming compound;    -   ii) a benzalkonium or benzethonium chloride;    -   iii) a polymeric biguanide; and    -   iv) a surfactant system comprising:        -   a. an alcohol ethoxylate; and        -   b. an alkylglucoside or alkylpolyglycoside.

In some embodiments, the alkoxy silyl ammonium film-forming agent is analkoxy silyl quaternary ammonium film forming agent. Alkoxy silylquaternary ammonium film forming agents are also known in the art asorganosilicon quaternary ammonium film forming compounds.

In some embodiments, the alkoxy silyl ammonium film-forming agent is acompound of formula (I):

[(R₁O)₃Si-A-N⁺(W)(X)(Y)]M⁻  (I)

wherein each R₁ is independently selected from hydrogen and —C₁₋₆alkyl;

A is a C₁₋₆alkylene group;

W and X are independently selected from —C₁₋₆alkyl;

Y is a C₁₀₋₂₀alkyl group; and

M is an anionic counterion.

In particular embodiments, one or more of the following applies:

R₁ is hydrogen, methyl or ethyl, especially methyl or ethyl, moreespecially methyl;

A is a C₂₋₄alkylene group, especially —CH₂CH₂CH₂—;

W and X are independently selected from methyl and ethyl, especiallymethyl;

Y is C₁₀₋₁₉alkyl; especially C₁₀ alkyl or C₁₈alkyl, more especiallyC₁₈alkyl; and

M is selected from F⁻, Cr⁻, Br⁻ and I⁻, especially Cr.

In particular embodiments, the alkoxy silyl ammonium film-formingcompound of formula (I) is selected from1-octadecanaminium-N,N-dimethyl-N-[3-trimethoxysilyl(propyl)]chloride(also known as 3-trimethoxysilylpropyl-N,N-dimethyl-N-octadecyl ammoniumchloride), 3-triethoxysilylpropyl-N,N-dimethyl-N-octadecyl ammoniumchloride, 3-triethoxysilylpropyl-N,N-dimethyl-N-isodecyl ammoniumchloride and 3-trimethoxysilylpropyl-N,N-dimethyl-N-isodecyl ammoniumchloride.

The alkoxy silyl ammonium film-forming compound is present in thecomposition in an amount in the range of 0.1% to 1.5% w/w, especiallyabout 0.3% to 1.0% w/w, more especially about 0.4 to 0.6% w/w of thecomposition. It is known that alkoxy silyl quaternary ammonium compoundshydrolyse in water forming the trihydroxy silicon functional group,therefore, for example, 3-trimethoxysilylpropyl-N,N-dimethyl_N-octadecylammonium chloride is hydrolysed to form as 3-trihydroxysilylpropyl-N,N-dimethyl-N-octadecyl ammonium chloride.

In some embodiments, the benzalkonium or benzethonium chloride compoundis a compound of formula (II):

wherein R₂ and R₃ are independently selected from C₁₋₆alkyl and

R₄ is C₈₋₁₈alkyl or —(CH₂CH₂O)₂[4-(1-dimethyl-3-dimethylbutyl)phenyl].

In particular embodiments, one or more of the following applies:

R₂ and R₃ are independently selected from methyl or ethyl, especiallymethyl; and

R₄ is selected from C₈, C₁₀, C₁₂, C₁₄, C₁₆ or C₁₈ alkyl or mixturesthereof or —(CH₂CH₂O)₂[4-(1-dimethyl-3-dimethylbutyl)phenyl].

The benzalkonium or benzethonium chloride compound is present in anamount in the range of about 0.1% to 1.0% w/w of the composition,especially about 0.1% to about 0.5% w/w, more especially about 0.1% to0.2% w/w of the composition, and even more especially about 0.1% to0.13% w/w of the composition in accordance with regulations according tothe Federal Drug Administration 21 CFR Parts 333 and 369—Tentative FinalMonograph for Health-Care Antiseptic Drug.

In some embodiments, the polymeric biguanide is a compound of formula(III):

wherein Z is absent or an organic divalent bridging group and each Z maybe the same or different throughout the polymer; n is at least 3,preferably 5 to 20 and X³ and X⁴ are independently selected from —NH₂,—NH—C(═NH)—NH—CN, optionally substituted alkyl, optionally substitutedcycloalkyl, optionally substituted aryl, optionally substitutedheterocyclyl and optionally substituted heteroaryl; or apharmaceutically acceptable salt thereof. Preferably, the molecularweight of the polymeric compound is at least 1,000 amu, more preferablybetween 1,000 amu and 50,000 amu. In a single composition, n may varyproviding a mixture of polymeric biguanides.

The above polymeric biguanide compounds and methods for theirpreparation are described in, for example, U.S. Pat. No. 3,428,576 andEast et. al., 1997.

In some embodiments, the polymeric biguanide for use in the inventionare polymeric alkylene biguanides of the following formula (IV):

wherein n is an integer from 3 to 500, m is an integer from 1 to 10,especially 3 (polyaminopropyl biguanide) or 6 (polyhexamethylenebiguanide, PHMB) and X³ and X⁴ are independently selected from —NH₂,—NH—C(═NH)—NH—CN, optionally substituted alkyl, optionally substitutedcycloalkyl, optionally substituted aryl, optionally substitutedheterocyclyl and optionally substituted aryl or a pharmaceuticallyacceptable salt thereof. In particular embodiments, n has an averagevalue of 3 to 15, more especially 3 to 12. A suitable polymericbiguanide is sold under the trade name Cosmocil CQ™ (Lonza),

The polymeric biguanide is present in the composition in an amount inthe range of 0.1% to 1.5% w/w, especially about 0.1% to about 1.0% w/w,more especially about 0.4% to about 0.6% w/w of the composition.

The surfactant system comprises an alcohol ethoxylate and an alkylglucoside or alkylpolyglycoside.

In particular embodiments, the alcohol ethoxylate is a C₁₀₋₁₈alcoholethoxylate, especially a C₁₂₋₁₆alcohol ethoxylate and more especially aC₁₂₋₁₅ alcohol ethoxylate group. In particular embodiments, the alcoholethoxylate comprises 6 to 16 ethoxylate groups, especially about 10 to14 ethoxylate groups. An example of a useful alcohol ethoxylate isC₁₂₋₁₅ Pareth-12™.

The alcohol ethoxylate is present in the composition in an amount in therange of 0.1% to 1.0% w/w, especially 0.2 to 0.8% w/w, more especiallyabout 0.4 to 0.6% w/w of the composition.

In particular embodiments, the alkylglucoside or alkylpolyglycoside is aC₈₋₁₆ alkylglucoside or alkylpolyglycoside, or a mixture thereof. Insome embodiments, the alkylglucoside or alkylpolyglycoside is selectedfrom caprylyl glucoside, caprylyl/capryl glucoside, octyl glucoside,decyl glucoside, dodecyl glucoside, coco glucoside, lauryl glucoside,caprylyl polyglycoside, caprylyl/capryl polyglycoside, decylpolyglycoside, dodecyl polyglycoside, coco polyglycoside and laurylpolyglycoside.

The alkyl glucoside or alkylpolyglycoside is present in the compositionin an amount in the range of 0.1% to 0.5% w/w, especially about 0.2 to0.4% w/w of the composition.

In some embodiments, particularly those applications where thesanitizing composition is for application to skin, such as hands orfeet, the composition may further comprise a moisturising, soothing,healing and antibacterial extract of aloe vera.

In some embodiments, the composition may also include other optionalcomponents such as rheological modifiers, pH adjustors, lubricants,humectants, fragrances and dyes. Suitable rheological modifiers includehydroxyethylcellulose, hydroxypropylcellulose and carbapol. Suitable pHadjustors include buffers, acids and bases. For example, a suitableacidic adjustor is acetic acid and a suitable basic adjustor is ammoniumhydroxide. Other suitable acidic adjustors include sorbic acid andcitric acid. Suitable lubricants or humectants include, for example,glycerin. Fragrances include essential oils and synthetic fragrances toprovide the desirable odour. For example, a suitable fragrance iscitronellol. Dyes or other colouring agents may also be included toimpart a suitable colour to the composition. A suitable colouring agentis FD&C Blue No 1.i

In some embodiments, the compositions are aqueous compositions whereinthe carrier comprises water, especially where the carrier is water. Inparticular embodiments, the compositions of the invention do not includealcohol such as ethanol or methanol as a component.

The compositions may conveniently be in the form of a liquid, gel,cream, lacquer or foam. In some embodiments, the composition isimpregnated in or coated on a textile to provide a wipe or swab. In someembodiments, the composition is dispersed from a dispenser, such as apump action dispenser, that dispenses a predetermined amount ofcomposition.

The gel formulations have a viscosity in the temperature range of 5° C.to 50° C. in the range of from 10,000 to 60,000 mPa·s, especially about16,000 to 50,000 mPa·s. The lower the ambient temperature, the greaterthe viscosity. For example, at 25° C., the viscosity is in the range offrom 31,000 to 32,000 mPa·s and at 50° C. the viscosity is in the rangeof from 16,000 to 17,000 mPa·s.

Definitions

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by those of ordinary skillin the art to which the invention belongs. Although any methods andmaterials similar or equivalent to those described herein can be used inthe practice or testing of the present invention, preferred methods andmaterials are described. For the purposes of the present invention, thefollowing terms are defined below.

The articles “a” and “an” are used herein to refer to one or to morethan one (i.e. to at least one) of the grammatical object of thearticle. By way of example, “an element” means one element or more thanone element.

As used herein, the term “about” refers to a quantity, level, value,dimension, size, or amount that varies by as much as 30%, 25%, 20%, 15%or 10% to a reference quantity, level, value, dimension, size, oramount.

Throughout this specification, unless the context requires otherwise,the words “comprise”, “comprises” and “comprising” will be understood toimply the inclusion of a stated step or element or group of steps orelements but not the exclusion of any other step or element or group ofsteps or elements.

As used herein, the term “alkyl” refers to a straight chain or branchedsaturated hydrocarbon group having 1 to 20 carbon atoms. Whereappropriate, the alkyl group may have a specified number of carbonatoms, for example, C₁₋₆alkyl which includes alkyl groups having 1, 2,3, 4, 5 or 6 carbon atoms in a linear or branched arrangement. Examplesof suitable alkyl groups include, but are not limited to, methyl, ethyl,n-propyl, i-propyl, n-butyl, i-butyl, t-butyl, n-pentyl, 2-methylbutyl,3-methylbutyl, 4-methylbutyl, n-hexyl, 2-methylpentyl, 3-methylpentyl,4-methylpentyl, 5-methylpentyl, 2-ethylbutyl, 3-ethylbutyl, heptyl,octyl, nonyl, decyl, isodecyl, undecyl, dodecyl and the like.

As used herein, the term “cycloalkyl” refers to a saturated cyclichydrocarbon. The cycloalkyl ring may include a specified number ofcarbon atoms. For example, a 3 to 8 membered cycloalkyl group includes3, 4, 5, 6, 7 or 8 carbon atoms. Examples of suitable cycloalkyl groupsinclude, but are not limited to, cyclopropyl, cyclobutyl, cyclopentyl,cyclohexyl, cycloheptyl and cyclooctyl.

As used herein, the term “aryl” is intended to mean any stable,monocyclic, bicyclic or tricyclic carbon ring system of up to 7 atoms ineach ring, wherein at least one ring is aromatic. Examples of such arylgroups include, but are not limited to, phenyl, naphthyl,tetrahydronaphthyl, indanyl, fluorenyl, phenanthrenyl, biphenyl andbinaphthyl.

As used herein, the term “alkylene” refers to a divalent saturatedhydrocarbon chain having 1 to 6 carbon atoms. Where appropriate, thealkylene group may have a specified number of carbon atoms, for example,C₁₋₆alkylene includes alkylene groups having 1, 2, 3, 4, 5 or 6 carbonatoms in a linear arrangement. Examples of suitable alkylene groupsinclude, but are not limited to, —CH₂—, —CH₂CH₂—, —CH₂CH₂CH₂—,—CH₂CH₂CH₂CH₂—, —CH₂CH₂CH₂CH₂CH₂— and —CH₂CH₂CH₂CH₂CH₂CH₂—.

The term “heterocyclic” or “heterocyclyl” as used herein, refers to acyclic hydrocarbon in which one to four carbon atoms have been replacedby heteroatoms independently selected from the group consisting of N,N(R), S, S(O), S(O)₂ and O. A heterocyclic ring may be saturated orunsaturated but not aromatic. A heterocyclic group may also be part of aspirocyclic group containing 1, 2 or 3 rings, two of which are in a“spiro” arrangement. Examples of suitable heterocyclyl groups includeazetidine, tetrahydrofuranyl, tetrahydrothiophenyl, pyrrolidinyl,2-oxopyrrolidinyl, pyrrolinyl, pyranyl, dioxolanyl, piperidinyl,2-oxopiperidinyl, pyrazolinyl, imidazolinyl, thiazolinyl, dithiolyl,oxathiolyl, dioxanyl, dioxinyl, dioxazolyl, oxathiozolyl, oxazolonyl,piperazinyl, morpholino, thiomorpholinyl, 3-oxomorpholinyl, dithianyl,trithianyl and oxazinyl.

The term “heteroaryl” as used herein, represents a stable monocyclic,bicyclic or tricyclic ring of up to 7 atoms in each ring, wherein atleast one ring is aromatic and at least one ring contains from 1 to 4heteroatoms selected from the group consisting of O, N and S. Heteroarylgroups within the scope of this definition include, but are not limitedto, acridinyl, carbazolyl, cinnolinyl, quinoxalinyl, quinazolinyl,pyrazolyl, indolyl, isoindolyl, 1H,3H-1-oxoisoindolyl, benzotriazolyl,furanyl, thienyl, thiophenyl, benzothienyl, benzofuranyl, benzodioxane,benzodioxin, quinolinyl, isoquinolinyl, oxazolyl, isoxazolyl,imidazolyl, pyrazinyl, pyridazinyl, pyridinyl, pyrimidinyl, pyrrolyl,tetrahydroquinolinyl, thiazolyl, isothiazolyl, 1,2,3-triazolyl,1,2,4-triazolyl, 1,2,4-oxadiazolyl, 1,2,4-thiadiazolyl, 1,3,5-triazinyl,1,2,4-triazinyl, 1,2,4,5-tetrazinyl and tetrazolyl. Particularheteroaryl groups have 5- or 6-membered rings, such as pyrazolyl,furanyl, thienyl, oxazolyl, indolyl, isoindolyl, 1H,3H-1-oxoisoindolyl,isoxazolyl, imidazolyl, pyrazinyl, pyridazinyl, pyridinyl, pyrimidinyl,pyrrolyl, thiazolyl, isothiazolyl, 1,2,3-triazolyl, 1,2,4-triazolyl and1,2,4-oxadiazolyl and 1,2,4-thiadiazolyl.

Alkyl, cycloalkyl, heterocyclyl, heteroaryl and aryl groups of theinvention may be optionally substituted with 1 to 5 groups selected fromOH, OC₁₋₆alkyl, Cl, Br, F, I, NH₂, NH(C₁₋₆alkyl), N(C₁₋₆alkyl)₂, SH,SC₁₋₆alkyl, CO₂H, CO₂C₁₋₆alkyl, CONH₂, CONH(C₁₋₆alkyl) orCON(C₁₋₆alkyl)₂.

As used herein, the term “divalent bridging group” refers to a radicalthat has a valence of two and is able to bind with two other groups.Examples of suitable divalent bridging groups include but are notlimited to —(CH₂)_(t)— where t is an integer from 1 to 10, —O—, —S—, adivalent saturated or aromatic carbocyclic ring or a heterocyclic orheteroaromatic ring or a combination of such divalent and/or cyclicmoieties. For example a saturated C₆ cyclic group would include —C₆H₁₀—,a C₆ aromatic group would include —C₆H₄—, a C₆ heterocyclic group wouldinclude

and a C₆ heteroaromatic would include

Other divalent bridging groups include alkylene groups (—CH₂-)_(t) inwhich one or more carbon atoms have been replaced by NH, S, O,

In a preferred embodiment the divalent bridging group is —(CH₂)_(t)—where t is an integer from 1 to 10, especially 1 to 6, more especially 3to 6.

The compounds of the invention may be in the form of pharmaceuticallyacceptable salts. It will be appreciated however thatnon-pharmaceutically acceptable salts also fall within the scope of theinvention since these may be useful as intermediates in the preparationof pharmaceutically acceptable salts or may be useful during storage ortransport. Suitable pharmaceutically acceptable salts include, but arenot limited to, salts of pharmaceutically acceptable inorganic acidssuch as hydrochloric, sulphuric, phosphoric, nitric, carbonic, boric,sulfamic, and hydrobromic acids, or salts of pharmaceutically acceptableorganic acids such as acetic, propionic, butyric, tartaric, maleic,hydroxymaleic, fumaric, maleic, citric, lactic, mucic, gluconic,benzoic, succinic, oxalic, phenylacetic, methanesulphonic,toluenesulphonic, benezenesulphonic, salicylic sulphanilic, aspartic,glutamic, edetic, stearic, palmitic, oleic, lauric, pantothenic, tannic,ascorbic and valeric acids.

Base salts include, but are not limited to, those formed withpharmaceutically acceptable cations, such as sodium, potassium, lithium,calcium, magnesium, ammonium and alkylammonium.

Basic nitrogen-containing groups may be quaternized with such agents aslower alkyl halide, such as methyl, ethyl, propyl, and butyl chlorides,bromides and iodides; dialkyl sulfates like dimethyl and diethylsulfate; and others.

The term “enclosed environment” refers to an indoor space or partialindoor space bound by at least one wall and a ceiling or roof. Anenclosed environment may include partially outdoor areas such as coveredbalconies and covered decks.

Uses of the sanitizing compositions of the invention

The sanitizing compositions of the present invention have antimicrobialactivity that is useful in applications such as hand sanitation inhospitals, nursing homes, schools, child care facilities, and otherplaces where there is a risk of the spread of microbial infection,especially antibiotic resistant microbial infection throughout apopulation, particularly patients in hospitals, the elderly in care andthe young in child care or school.

The compositions of the present invention may readily be used as handsanitizers to kill pathogens on the hands and avoid spreading ofinfection. The hand sanitizers may be applied to the hands in anysuitable manner, for example, from a tube or pump action container or inthe air stream of a hand drying device.

Without wishing to be bound by theory, it is thought that thecomposition forms a protective antimicrobial barrier on the skin. Thecompositions therefore not only provide control of microbes that arepresent when the composition is applied, they further protect the userfrom re-infection or infection upon exposure to further microbes theycontact.

The sanitizing composition is effective against a wide range ofpathogens which are either killed or inactivated following applicationof the composition. Pathogens which are killed or inactivated by thesanitizing compositions of the present invention include:

Gram Positive Bacteria

Bacillus sp. (vegetative cell), Corynebacterium diptheriae, Clostridiumdifficile, Enterococcus faecalis, Enterococcus hirae, Listeriamonocytogenes, Micrococcus luteus, Micrococcus sp., Mycobacteriumtuberculosis, Mycobacterium smegmatis, Propionibacterium acnes,Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcushaemolyticus, Staphylococus hominis, Staphylococcus saprophyticus,Streptococcus faecalis, Streptococcus mutans, Streptococcus pneumoniaand Streptococcus pyogenes.

Gram Negative Bacteria

Acinetobacter baumannii, Acinetobacter calcoaceticus, Aeromonashydrophilia, Bacterioides fragilis, Burkholderia cepacia Citrobacterdeversus, Citrobacter freundi, Enterobacter aerogenes, Enterobacteraglomerans, Enterobacter cloacae, Enterobacter gergoviae, Enterococcus,Escherichia coli, Escherichia coli O157:H7, Eupenicillium levitum,Haemophilus influenza, Klebsiella oxytoca, Klebsiella pneumoniae,Klebsiella terriena, Legionella pneumophila, Morganella morganii,Penicillium luteum, Proteus mirabilis, Proteus vulgaris, Pseudomonasaeruginosa, Pseudomonas fluorscens, Salmonella cholera suis, Salmonellatyphi, Salmonella typhimurium, Salmonella enterica, Serratialiquifaciens, Serratia marcescens and Xanthomonas campestris.

Viruses

Adenovirus Type II & IV, Bovine Adenovirus Type I & IV, Murine Norovirus1, Feline pneumonitis, Herpes Simplex Type I, Herpes Simplex Type II,HIV-1 (AIDS), Influenza A2 (Aichi), Influenza A2 (Asian), Influenza B,Influenza (H1N1), Mumps, Parinfluenza (Sendai), Rous Sarcoma, ReovirusType I, Simian Virus 40, Vaccinia, MS2 (bacteriophage), PRD1(bacteriophage), Rhinoviruses and Enterovirus 71.

Fungi, Algae, Mould, Yeast, Spores

Alterania alternata, Aphanizomenon sp., Aspergillus flavus, Aspergillusniger, Aspergillus sydowii, Aspergillus terreus, Aspergillus versicolor,Aspergillus verrucaria, Aureobasidium pullans, Candida albicans, Candidapseudotropocalis, Chaetomium globsum, Cladosporium cladosporioides,Chlorella vulgaris, Dreschslera australiensis, Epidermophyton sp.,Epidermophyton floccosum, Gliomastix cerealis, Gloeophyllum trabeum,Microsporum sp., Microsporum audouinii, Monilia grisea, Oscillatoria,Penicillium chrysogenum, Pencillium commune, Penicillium funiculosum,Penicillium pinophilium, Penicillium variable, Phoma fimeti, Pithomyceschartarum, Poria placenta, Scenedesmus, Saccharonyces cerevisiae,Scolecobasidium humicola, Selenastrum sp., Trichoderma viride,Trichophyton interdigitale, Trichophyton maidson, Trichophytonmentogrophytes, Trichophyton rubrum and Trichophyton sp.

Protozoa Parasites Cryptosporidium parvum (oocysts).

In light of their antifungal activity, the compositions of the presentinvention may also be useful in treating or preventing fungal infectionof the skin, particularly those infections caused by Tinea, includingAthlete's foot (Tinea pedis), Tinea of the scalp (Tinea capitis), Tineaof the hands (Tinea manuum), Tinea of the beard (Tinea barbae), jockitch (Tinea cruris) and Tinea of the body (Tinea corporis) or Candidaalbicans such as Intertrigo. In particular embodiments, the compositionsuseful in this method include aloe vera to assist in alleviatingitching. In these embodiments, the composition is applied to theinfected skin regularly, for example, multiple times per day, or oncedaily.

The compositions of the invention have been found to have not onlyimmediate sanitizing effects on skin but also have been found to bepersistent on the skin, providing a long-lasting protective effect. Theprotective effect can last for 3, 6 or 12 hours or more, or may lastthrough a number of hand washing episodes or if hands are protected bysurgical gloves. Immediate antimicrobial activity was demonstrated by agreater than 5.8 Log 10 reduction in bacterial flora immediately afteruse. Persistent activity is observed at the same order of magnitude 3and 6 hours post treatment. Even 12 hours after treatment wherein thecomposition was applied to hands kept occluded within surgical gloves,only minimal lowering of antibacterial activity was observed (4 log₁₀reduction, 99.99%).

In yet another embodiment of the present invention, the compositions maybe useful for sanitizing the air in an enclosed environment, such as aroom or building. In these embodiments, the composition may be a liquidcomposition that is dispensed from a spray or aerosol dispenser. In someembodiments, the composition may be dispersed from a device byatomisation or formation of a fog or in an airstream. Suitable devicesare described in WO 2013/149285. In particular embodiments, the buildingis a hospital. In some embodiments, the room is a ward of a hospital. Insome embodiments, the sanitizing composition further comprises afragrance to assist with deodorizing the air. Without wishing to bebound by theory, it is thought that negatively charged dust andbacterial particles in the air react with the positively charged aerosoldroplets of composition of the invention. Agglomeration of particlesoccurs and the particles drop out of the air.

The invention will now be described with reference to the followingExamples which illustrate some preferred aspects and embodiments of thepresent invention. However, it is to be understood that theparticularity of the following description of the invention is not tosupersede the generality of the preceding description of the invention.

Examples Example 1: Antimicrobial Gel Formulation with Aloe Vera(Citronella fragrance)

An antimicrobial formulation of a fragrant gel was made with thefollowing components:

1) Water 95.52% 2) Hydroxyethylcellulose 1.55% 3) 1-Octadecanaminium-N,N-dimethyl- 0.5%N-(3-trimethoxysilyl)propyl)chloride 4) C₁₂-C₁₅ Pareth-12 ™ 0.50% 5)Polymeric biguanidine 0.5% 6) Acetic acid 0.3% 7) Caprylyl glucoside0.3% 8) DL citronellol 0.3% 9) Ammonium hydroxide 0.2% 10)  Benzalkoniumchloride 0.13% 11)  Glycerin 0.10% 12)  Aloe Extract 0.05% 13)  Blue No1 0.0001%

In Part A: Water was heated to 40° C. and the pH adjusted to pH 8.Hydroxethyl cellulose was added to the water and dissolved.

In Part B C₁₂-C₁₅ Pareth-12™, Caprylyl glucoside and Polymericbiguanidine as added to water preheated to 40° C. and the mixture wasstirred.

The parts A and B were combined and the other ingredients were addedmaintaining the mixture at 40° C. The pH was adjusted to pH of 5.5 withacetic acid. The formulation was then cooled.

Example 2: Unscented Antimicrobial Gel Formulation with Aloe Vera

An antimicrobial formulation of an unscented gel was made with thefollowing components:

1) Water 95.82% 2) Hydroxyethylcellulose 1.55% 3)1-Octadecanaminium,N,N,dimethyl- 0.5% N-(3-trimethoxysilyl) propyl)chloride 4) C₁₂-C₁₅ Pareth-12 ™ 0.50% 5) Polymeric biguanidine 0.5% 6)Acetic acid 0.3% 7) Caprylyl glucoside 0.3% 8) Ammonium hydroxide 0.2%9) Benzalkonium chloride 0.13% 10)  Glycerin 0.10% 11)  Aloe Extract0.05% 12)  Blue No 1 0.0001%

In Part A: Water was heated to 40° C. and the pH adjusted to pH 8.Hydroxethyl cellulose was added to the water and dissolved.

In Part B C₁₂-C₁₅ Pareth-12™, Caprylyl glucoside and Polymericbiguanidine as added to water preheated to 40° C. and the mixture wasstirred.

The parts A and B were combined and the other ingredients were addedmaintaining the mixture at 40° C. The pH was adjusted to pH of 5.5 withacetic acid. The formulation was then cooled.

Example 3: Unscented Antimicrobial Liquid or Foam Formulation with AloeVera

A formulation was prepared with the following components:

1) Water 97.23% 2) 1-Octadecanaminium,N,N,dimethyl- 1.0%N-(3-trimethoxysilyl) propyl) chloride 3) C₁₂-C₁₅ Pareth-12 ™ 0.50% 4)Polymeric biguanidine 1.0% 5) Sorbic acid 0.1% 6) Caprylyl glucoside0.3% 7) Benzalkonium chloride 0.13% 8) Glycerin 0.10% 9) Aloe Extract0.05% 10)  Blue No 1 0.001%

The components are blended to form a liquid. Foam may be producedthrough a foam forming nozzle.

Example 4: Scented Antimicrobial Liquid or Foam Formulation with AloeVera (Citronella fragrance)

A formulation was prepared from the following components:

1) Water 97.23% 2) 1-Octadecanaminium,N,N,dimethyl- 1.0%N-(3-trimethoxysilyl) propyl) chloride 3) C₁₂-C₁₅ Pareth-12 ™ 0.50% 4)Polymeric biguanidine 1.0% 5) Sorbic acid 0.1% 6) Citronellol 0.03 7)Caprylyl glucoside 0.3% 8) Benzalkonium chloride 0.13% 9) Glycerin 0.10%10)  Aloe Extract 0.05% 11)  Blue No 1 0.001%

The components are blended to form a liquid. Foam may be producedthrough a foam forming nozzle.

Example 5: Antimicrobial Gel Formulation (Citronella fragrance)

An antimicrobial formulation of a fragrant gel was made with thefollowing components:

1) Water 95.57% 2) Hydroxyethylcellulose 1.55% 3) 1-Octadecanaminium-N,N-dimethyl- 0.5%N-(3-trimethoxysilyl)propyl)chloride 4) C₁₂-C₁₅ Pareth-12 ™ 0.50% 5)Polymeric biguanidine 0.5% 6) Acetic acid 0.3% 7) Caprylyl glucoside0.3% 8) DL citronellol 0.3% 9) Ammonium hydroxide 0.2% 10)  Benzalkoniumchloride 0.13% 11)  Glycerin 0.10% 12)  Blue No 1 0.0001%

In Part A: Water was heated to 40° C. and the pH adjusted to pH 8.Hydroxethyl cellulose was added to the water and dissolved.

In Part B C₁₂-C₁₅ Pareth-12™, Caprylyl glucoside and Polymericbiguanidine as added to water preheated to 40° C. and the mixture wasstirred.

The parts A and B were combined and the other ingredients were addedmaintaining the mixture at 40° C. The pH was adjusted to pH of 5.5 withacetic acid. The formulation was then cooled.

Example 6: Unscented Antimicrobial Gel Formulation

An antimicrobial formulation of an unscented gel was made with thefollowing components:

1) Water 95.87% 2) Hydroxyethylcellulose 1.55% 3)1-Octadecanaminium,N,N,dimethyl- 0.5% N-(3-trimethoxysilyl) propyl)chloride 4) C₁₂-C₁₅ Pareth-12 ™ 0.50% 5) Polymeric biguanidine 0.5% 6)Acetic acid 0.3% 7) Caprylyl glucoside 0.3% 8) Ammonium hydroxide 0.2%9) Benzalkonium chloride 0.13% 10)  Glycerin 0.10% 11)  Blue No 10.0001%

In Part A: Water was heated to 40° C. and the pH adjusted to pH 8.Hydroxethyl cellulose was added to the water and dissolved.

In Part B C₁₂-C₁₅ Pareth-12™, Caprylyl glucoside and Polymericbiguanidine as added to water preheated to 40° C. and the mixture wasstirred.

The parts A and B were combined and the other ingredients were addedmaintaining the mixture at 40° C. The pH was adjusted to pH of 5.5 withacetic acid. The formulation was then cooled.

Example 7: Unscented Antimicrobial Liquid or Foam Formulation

A formulation was prepared with the following components:

1) Water 97.28% 2) 1-Octadecanaminium,N,N-dimethyl- 1.0%N-(3-trimethoxysilyl) propyl) chloride 3) C₁₂-C₁₅ Pareth-12 ™ 0.50% 4)Polymeric biguanidine 1.0% 5) Sorbic acid 0.1% 6) Caprylyl glucoside0.3% 7) Benzalkonium chloride 0.13% 8) Glycerin 0.10% 9) Blue No 10.001%

The components are blended to form a liquid. Foam may be producedthrough a foam forming nozzle.

Example 8: Scented Antimicrobial Liquid or Foam Formulation

A formulation was prepared from the following components:

1) Water 97.28% 2) 1-Octadecanaminium,N,N,dimethyl- 1.0%N-(3-trimethoxysilyl) propyl) chloride 3) C₁₂-C₁₅ Pareth-12 ™ 0.50% 4)Polymeric biguanidine 1.0% 5) Sorbic acid 0.1% 6) Citronellol 0.03 7)Caprylyl glucoside 0.3% 8) Benzalkonium chloride 0.13% 9) Glycerin 0.10%10)  Blue No 1 0.001%

The components are blended to form a liquid. Foam may be producedthrough a foam forming nozzle.

Example 9: Antimicrobial Efficacy of Formulations 2 and 3

The formulations of Examples 2 and 3 were subjected to the Time-KillAssay for Antimicrobial Agents for 25 microbes in the Over the Counter(OTC) Antimicrobial Drug Monograph [FDA 1994, ASTM 2315, EN1276, EN1040(bacteria) and EN1275 (fungi)]. The formulations of Examples 2 and 3were compared to a 70% v/v ethanol hand sanitizer as a referencestandard.

Briefly, in this method, a sample of each formulation was inoculatedwith a suspension of the test microorganism. After a series ofpre-selected exposure times, a sample of the suspension is removed,neutralized and quantitatively assayed for surviving testmicroorganisms. After incubation, the surviving microorganisms werecounted and the percent and log₁₀ reductions determined at each timepoint against a control sample that did not contain formulation.

The results are shown in Table 1:

TABLE 1 Time-Kill Test Summary Showing Wide Spectrum & High EfficacyHand Sanitizer Hand Sanitizer Gel with Liquid/Foam with Micro-organismTime 70% Alcohol Gel Aloe Vera Log₁₀ Aloe Vera Log₁₀ (Strain #) (Sec)Hand Sanitizer reduction (%) reduction (%) Gram-Negative Bacteria 1.Acinetobacter baumannii 15 sec >6.04 (99.9999%) >6.02 (99.9999%) >6.02(99.9999%) (ATCC #19606) 30 sec >6.04 (99.9999%) >6.02 (99.9999%) >6.02(99.9999%) 60 sec >6.04 (99.9999%) >6.02 (99.9999%) >6.02 (99.9999%) 2.Bacteroides fragilis 15 sec >6.08 (99.9999%)  6.03 (99.9999%)  6.03(99.9999%) (ATCC# 25285) 30 sec >6.08 (99.9999%)  6.03 (99.9999%)  6.03(99.9999%) 60 sec >6.08 (99.9999%)  6.03 (99.9999%)  6.03 (99.9999%) 3.Haemophilus influenzae 15 sec >6.18 (99.9999%) >6.12 (99.9999%) >6.12(99.9999%) (ATCC #33930) 30 sec >6.18 (99.9999%) >6.12 (99.9999%) >6.12(99.9999%) 60 sec >6.18 (99.9999%) >6.12 (99.9999%) >6.12 (99.9999%) 4.Enterobacter aerogenes 15 sec >6.08 (99.9999%) >6.02 (99.9999%) >6.02(99.9999%) (ATCC #13048) 30 sec >6.08 (99.9999%) >6.02 (99.9999%) >6.02(99.9999%) 60 sec >6.08 (99.9999%) >6.02 (99.9999%) >6.02 (99.9999%) 5.Escherichia coli 15 sec >6.08 (99.9999%) >6.01 (99.9999%) >6.01(99.9999%) (ATCC #11229) 30 sec >6.08 (99.9999%) >6.01 (99.9999%) >6.01(99.9999%) 60 sec >6.08 (99.9999%) >6.01 (99.9999%) >6.01 (99.9999%) 6.Escherichia coli 15 sec >6.08 (99.9999%) >6.58 (99.9999%) >6.78(99.9999%) (ATCC #10536) 30 sec >6.08 (99.9999%) >6.58 (99.9999%) >6.78(99.9999%) 60 sec >6.08 (99.9999%) >6.58 (99.9999%) >6.78 (99.9999%) 7.Escherichia coli 30 sec >6.04 (99.9999%) >5.0 (99.999%) (ATCC #25922) 60sec >6.04 (99.9999%) >5.0 (99.999%) 8. Klebsiella oxytoca 15 sec >6.04(99.9999%) >6.03 (99.9999%) >6.03 (99.9999%) (ATCC #13182) 30 sec >6.08(99.9999%) >6.03 (99.9999%) >6.03 (99.9999%) 60 sec >6.08(99.9999%) >6.03 (99.9999%) >6.03 (99.9999%) 9. Escherichia coli 15sec >6.08 (99.9999%) >4.0 (>99.99%) (O157:H7) 10. Klebsiella pneumoniae15 sec >6.18 (99.9999%) >5.0 (99.999%) (ATCC #51504) 30 sec >6.18(99.9999%) >5.0 (99.999%) 60 sec >6.18 (99.9999%) >5.0 (99.999%) 11.Klebsiella pneumoniae 15 sec >6.08 (99.9999%) >6.04 (99.9999%) >6.04(99.9999%) (ATCC #4352) 30 sec >6.08 (99.9999%) >6.04 (99.9999%) >6.04(99.9999%) 60 sec >6.08 (99.9999%) >6.04 (99.9999%) >6.04 (99.9999%) 12.Pseudomonas aeruginosa 15 sec >6.08 (99.9999%) >6.58 (99.9999%) >6.78(99.9999%) (ATCC #9027) 30 sec >6.08 (99.9999%) >6.58 (99.9999%) >6.78(99.9999%) 60 sec >6.08 (99.9999%) >6.58 (99.9999%) >6.78 (99.9999%) 13.Pseudomonas aeruginosa 15 sec >6.08 (99.9999%) >6.23 (99.9999%) >6.23(99.9999%) (ATCC #27853) 30 sec >6.08 (99.9999%) >6.23 (99.9999%) >6.23(99.9999%) 60 sec >6.08 (99.9999%) >6.23 (99.9999%) >6.23 (99.9999%) 14.Pseudomonas aeruginosa 15 sec >5.0 (99.999%) (ATCC #27853) 30 sec >5.0(99.999%) 60 sec >5.0 (99.999%) 75. Pseudomonas aeruginosa 15 sec >5.0(99.999%) (ATCC #15442) 30 sec >5.0 (99.999%) 60 sec >5.0 (99.999%) 16.Proteus mirabilis 15 sec >6.01 (99.9999%) >6.12 (99.9999%) >6.12(99.9999%) (ATCC #7002) 30 sec >6.01 (99.9999%) >6.12 (99.9999%) >6.12(99.9999%) 60 sec >6.01 (99.9999%) >6.12 (99.9999%) >6.12 (99.9999%) 17.Serratia marcescens 15 sec >6.03 (99.9999%) >6.12 (99.9999%) >6.12(99.9999%) (ATCC #14756) 30 sec >6.03 (99.9999%) >6.12 (99.9999%) >6.12(99.9999%) 60 sec >6.03 (99.9999%) >6.12 (99.9999%) >6.12 (99.9999%) 78.Salmonella enterica 60 sec >5.0 (99.999%) GFS-(ATCC #10398) 19.Salmonella typhimurium ¹ 15 sec >4.0 (99.99%)  Gram-Positive Bacteria20. Staphylococcus aureus 15 sec >6.06 (99.9999%) >6.56 (99.9999%)  6.76(99.9999%) (ATCC #6538) 30 sec >6.06 (99.9999%) >6.56 (99.9999%)  6.76(99.9999%) 60 sec >6.06 (99.9999%) >6.56 (99.9999%)  6.76 (99.9999%) 21.Staphylococcus aureus 15 sec >6.08 (99.9999%) >6.11 (99.9999%) >6.11(99.9999%) (ATCC #29213) 30 sec >6.08 (99.9999%) >6.11 (99.9999%) >6.11(99.9999%) 60 sec >6.08 (99.9999%) >6.11 (99.9999%) >6.11 (99.9999%) 22.Staphylococcus epidermidis 15 sec >6.28 (99.9999%) >6.22(99.9999%) >6.22 (99.9999%) (ATCC #12228) 30 sec >6.28 (99.9999%) >6.22(99.9999%) >6.22 (99.9999%) 60 sec >6.28 (99.9999%) >6.22(99.9999%) >6.22 (99.9999%) 23. Staphylococcus hominis 15 sec >6.22(99.9999%) >6.21 (99.9999%) >6.21 (99.9999%) (ATCC #27844) 30 sec >6.22(99.9999%) >6.21 (99.9999%) >6.21 (99.9999%) 60 sec >6.22(99.9999%) >6.21 (99.9999%) >6.21 (99.9999%) 24. Staphylococcushaemolyticus 15 sec >5.0 (99.999%) (ATCC #43253) 30 sec >5.0 (99.999%)60 sec >5.0 (99.999%) 25. Staphylococcus haemolyticus 15 sec >6.16(99.9999%) >6.12 (99.9999%) >6.12 (99.9999%) (ATCC #29970) 30 sec >6.16(99.9999%) >6.12 (99.9999%) >6.12 (99.9999%) 60 sec >6.16(99.9999%) >6.12 (99.9999%) >6.12 (99.9999%) 26. Staphylococcussaprophyticus 15 sec >6.16 (99.9999%) >6.11 (99.9999%) >6.11 (99.9999%)(ATCC #35552) 30 sec >6.16 (99.9999%) >6.11 (99.9999%) >6.11 (99.9999%)60 sec >6.16 (99.9999%) >6.11 (99.9999%) >6.11 (99.9999%) 27.Micrococcus luteus 15 sec >6.26 (99.9999%) >6.22 (99.9999%) >6.22(99.9999%) (ATCC #7468) 30 sec >6.26 (99.9999%) >6.22 (99.9999%) >6.22(99.9999%) 60 sec >6.26 (99.9999%) >6.22 (99.9999%) >6.22 (99.9999%) 28.Streptococcus pyogenes 15 sec >6.08 (99.9999%) >6.03 (99.9999%) >6.03(99.9999%) (ATCC #19615) 30 sec >6.08 (99.9999%) >6.03 (99.9999%) >6.03(99.9999%) 60 sec >6.08 (99.9999%) >6.03 (99.9999%) >6.03 (99.9999%) 29.Enterococcus faecalis 15 sec >6.08 (99.9999%) >6.01 (99.9999%) >6.01(99.9999%) (ATCC# 29212) 30 sec >6.08 (99.9999%) >6.01 (99.9999%) >6.01(99.9999%) 60 sec >6.08 (99.9999%) >6.01 (99.9999%) >6.01 (99.9999%) 30.Enterococcus hirae 15 sec >6.06 (99.9999%) >6.56 (99.9999%) >6.76(99.9999%) (ATCC #6057) 30 sec >6.06 (99.9999%) >6.56 (99.9999%) >6.76(99.9999%) 60 sec >6.06 (99.9999%) >6.56 (99.9999%) >6.76 (99.9999%) 31.Streptococcus pneumoniae 15 sec >6.08 (99.9999%) >6.06 (99.9999%) >6.06(99.9999%) (ATCC #8043) 30 sec >6.08 (99.9999%) >6.06 (99.9999%) >6.06(99.9999%) 60 sec >6.08 (99.9999%) >6.06 (99.9999%) >6.06 (99.9999%)Fungi (Yeast & Mold) 32. Candida albicans 15 sec >5.42 (99.9995%) >5.22(99.999%)  >5.12 (99.9999%) (ATCC# 10231) 30 sec >5.42 (99.9995%) >5.22(99.999%)  >5.12 (99.9999%) 60 sec >5.42 (99.9995%) >5.22(99.999%)  >5.12 (99.9999%) 33. Aspergillus niger 15 sec >5.54(99.9996%) >5.04 (99.999%)  >5.44 (99.9995%) (ATCC# 16404) 30 sec >5.54(99.9996%) >5.04 (99.999%)  >5.44 (99.9995%) 60 sec >5.54(99.9996%) >5.04 (99.999%)  >5.44 (99.9995%)

Example 10: Viral Efficacy of Sanitizer Composition

The sanitizer formulation of Example 6 was tested for efficacy againstNorwalk Virus, on fresh, washed, shaved and sterilized porcine skin tosimulate human skin contact. The virus stock is prepared using thefollowing materials. Norwalk Virus (MNV-1) animal CW1, ATCC PTA-5935hosted in RAW 264.7 Murine cells, ATCC T1B71. Once confluency isobtained, the stock was tested on a set of porcine skin, M121015D, pads(3″×6″ pads) without the sanitizer (control) to ensure this can be usedas a suitable substrate for challenging the product. On all three setsof pig skin pads, the Norwalk virus is applied, dried and treated withsanitizer composition. The pads are sampled and evaluated for viabilityof Norwalk virus. The second and third sets of pads were repeatedlywashed with a mild non-antimicrobial soap to simulate hand-washing. Thesecond set of pads were washed five times and the third set of padswashed nine times. Each set of pads were sampled to evaluate viabilityof Norwalk virus. Following the five and nine washings, each set of padswere contaminated again with Norwalk virus, dried and sampled todetermine long-term protection of the initial application of theproduct. An additional control was added to ensure no interference fromthe mild antimicrobial soap washings of the porcine skin pads on theprocedure.

The results are shown in Table 2.

TABLE 2 Sample ID Description Application Results Comments Control Virusapplied None 100% infected Plaque assay and dried on performed. porcineskin Viability followed by confirmed rinsing following 72 hours ofincubation Control Porcine pads Mild 100% infected Plaque assay werewashed 9 antimicrobial performed. times followed salt Viability byconfirmed contamination following 72 with virus stock hours ofincubation Product applied Product applied Composition of Dead Cells areto porcine pads Example 6 infected and and rubbed to applied; No deaddryness soap washing Product applied Product applied Composition of DeadCells are to porcine pads Example 6 infected and and rubbed to applieddead dryness Product applied Product applied Composition of Dead Cellsare 5 x washing to porcine pads Example 6 infected and and rubbed toapplied. Mild dead dryness; antimicrobial washed 5 x soap Productapplied Product applied Composition of 50-60% Some viability 5 x washingto porcine pads Example 6 infected indicating some Recontamination andrubbed to applied. Mild level of with stock virus dryness; antimicrobialprotection washed 5 x. soap following five Virus reapplied washings anddried followed by rinsing after 5 min Product applied Product appliedComposition of Dead Cells infected to porcine pads Example 6 and deadand rubbed to applied dryness Product applied Product appliedComposition of Dead Cells are 9 x washing to porcine pads Example 6infected and and rubbed to applied. Mild dead dryness; antimicrobialwashed 5 x. soap Product applied Product applied Composition of 100%infected Viability 9 x washing to porcine pads Example 6 indicating noRecontamination and rubbed to applied. Mild level of with stock virusdryness; antimicrobial protection washed 5 x. soap following nine Virusreapplied washings and dried followed by rinsing after 5 min

Example 11: Antibacterial Efficacy

The experiment was executed to evaluate the effectiveness of thesanitizer product of Example 6 for a Time-Kill Assay using the procedureoutlined I ASTM method E2315-03 on the following species and strains:Escherichia coli (ATCC 11229), Salmonella enterica (ATCC 10306),Staphylococcus aureus (ATCC 6538), Streptococcus pyrogenes (ATCC 19615)and Pseudomonas aeruginosa (ATCC 15442). Each organism was checked andevaluated independent of one another to ensure direct effects on theorganism by the formulation and to eliminate any effects of onebacterium on another. All media preparation was specific to eachorganism. Samples were drawn and plated in duplicate. The results arereported as the mean of the duplicate samples. All testing was conductedat ambient temperature. Streptococcus pyrogenes was incubated in a 5%carbon dioxide environment for successful growth. The microorganismswere challenged with the letheen broth used for neutralizing thesanitizer composition, to ensure it did not have any problematic effectson the growth of the organism.

The results are shown in Table 3.

TABLE 3 Comments Time in Results Conditions and seconds (CFUs) mediasupport Organism Control Growth growth Escherichia coli 0 0 No growthwas 15 0 observed at any time 30 0 60 0 Salmonella enterica 0 5 Theorganism 15 2 showed some ability 30 1 to resist the effects 60 0 of thesanitizer but succumbed at 60 seconds Staphylococcus 0 0 No growth wasaureus 15 0 observed at any time 30 0 60 0 Streptococcus 0 7 Theorganism pyrogenes 15 4 showed some ability 30 1 to resist the effects60 0 of the sanitizer but succumbed at 60 seconds Pseudomonas 0 0 Nogrowth was aeruginosa 15 0 observed at any time 30 0 60 0

Example 12: Antibacterial Efficacy

The experiment was executed to evaluate the effectiveness of thesanitizer product of Example 2 for a Time-Kill Assay using the procedureoutlined I ASTM method E2315-03 on the following species and strains:Escherichia coli (ATCC 11229), Salmonella enterica (ATCC 10306)Staphylococcus aureus (ATCC 6538), Streptococcus pyrogenes (ATCC 19615)and Pseudomonas aeruginosa (ATCC 15442). Each organism was checked andevaluated independent of one another to ensure direct effects on theorganism by the formulation and to eliminate any effects of onebacterium on another. All media preparation was specific to eachorganism. Samples were drawn and plated in duplicate.

The results are reported as the mean of the duplicate samples. Alltesting was conducted at ambient temperature. Streptococcus pyrogeneswas incubated in a 5% carbon dioxide environment for successful growth.The microorganisms were challenged with the letheen broth used forneutralizing the sanitizer composition, to ensure it did not have anyproblematic effects on the growth of the organism.

The results are shown in Table 4.

TABLE 4 Comments Time in Results Conditions and seconds (CFUs) mediasupport Organism Control Growth growth Escherichia coli 0 0 No growthwas observed at any time 15 0 30 0 60 0 Salmonella enterica 0 5 Theorganism 15 2 showed some ability 30 1 to resist the effects 60 0 of thesanitizer but succumbed at 60 seconds Staphylococcus 0 0 No growth wasaureus 15 0 observed at any time 30 0 60 0 Streptococcus 0 7 Theorganism pyrogenes 15 4 showed some ability 30 1 to resist the effects60 0 of the sanitizer but succumbed at 60 seconds Pseudomonas 0 0 Nogrowth was observed at any time aeruginosa 15 0 30 0 60 0

Example 13: Antibacterial Efficacy

The experiment was executed to evaluate the effectiveness of thesanitizer product of Example 2 for a Time-Kill Assay using the procedureoutlined in ASTM method E2315-03 on the following species and strains:Escherichia coli (ATCC 25922), Klebsiella pneumoniae (ATCC 51504),Pseudomonas aeruginosa (ATCC 27853), Staphylococcus aureus (ATCC 29213)and Staphylococcus haemolyticus (ATCC 43253). Each organism was checkedand evaluated independent of one another to ensure direct effects on theorganism by the formulation and to eliminate any effects of onebacterium on another. All media preparation was specific to eachorganism. Samples were drawn and plated in duplicate. The results arereported as the mean of the duplicate samples. All testing was conductedat ambient temperature.

The results are shown in Table 5.

TABLE 5 Comments Time in Results Conditions and seconds (CFUs) mediasupport Organism Control Growth growth Escherichia coli 0 2 Someviability but 15 0 succumbed by 15 30 0 seconds 60 0 Klebsiella 0 0 Nogrowth was pneumoniae 15 0 observed at any time 30 0 60 0 Pseudomonas 00 No growth was aeruginosa 15 0 observed at any time 30 0 60 0Staphylococcus 0 0 No growth was aureus 15 0 observed at any time 30 060 0 Staphylococcus 0 0 No growth was haemolyticus 15 0 observed at anytime 30 0 60 0

Example 14: Persistent Antibacterial Efficacy

Samples of porcine skin were cut into pads measuring about 3×6 inchesand sterilized with 70% ethanol (2 mL). A test group were treated with acomposition of Example 2 and left at room temperature for up to fourhours. At predetermined intervals, inocula of MRSA (ATCC #33592), VRE(ATCC #51575) and CRE (Klebsiella pneumoniae, ATCC # BAA-1705). The padswere washed and treated to obtain any living bacteria and samples wereplated, incubated and counted to determine live bacteria. The sampleswere compared to samples treated in the same manner but without skinsanitizer. Inoculations were made at 2 minutes, 1 hour and 5 hours afterapplication of the sanitizer composition.

All samples at each timepoint had 99.9999% (>5.8 log₁₀ reduction)bacterial growth reduction compared to those samples that had not beentreated with sanitizer composition.

Example 15: Persistent Antibacterial Efficacy

The protocol for Example 14 was repeated with Staphylococcus aureus(ATCC #12600) with inoculation times of 2 minutes, 1 hour, 2 hours, 4hours, 8 hours, 16 hours and 24 hours.

The results show an initial 3 log₁₀ reduction in bacterial growth,followed by 99% suppression at 1 hour, 98% suppression at 2 hours, 97%suppression at 4 hours, 85% suppression at 8 hours, 80% suppression at16 hours and 54% suppression at 24 hours.

Example 16: Efficacy of Example 2 as a Handrub

The composition of Example 2 was tested for compliance with requirementsfor chemical disinfectants and antiseptics in accordance with EuropeanStandard BS EN 1500:2013 Chemical Disinfectants and Antiseptics—Hygienic Handrub—Test Method and Requirements. The test organism wasEscherichia coli K12 NCTC 10538 which was obtained as a freeze driedampoule and was reconstituted using Tryptone Soy Broth and incubated toachieve a concentration of 2×10⁹ Cfu/mL. The reference standard waspropan-2-ol 60% v/v solution in sterile water. There were no deviationsfrom the standard test method.

Human volunteer's hands were washed for 1 minute with diluted soft soap(5 mL), rinsed in running water and dried with a paper towel for atleast 30 seconds. The hands were immersed up to the mid-metacarpals forfive seconds and the liquid was allowed to drain back into the containerfor a maximum of 30 seconds before allowing to air dry for threeminutes.

The reference standard (3.0 mL) was applied and rubbed for 30 seconds.This was repeated with a second portion of reference standard (3.0 mL)and rubbing for a further 30 seconds. This procedure was repeated for 20volunteers.

This protocol was repeated on 20 volunteers using the composition ofExample 2.

Analysis of the results showed that the reference standard had a MeanLog Reduction Factor of 3.89 and the composition of Example 2 had a MeanLog Reduction Factor of 4.22. The Mean Log Reduction Factor of the testproduct was greater than that of the reference standard, therefore thecomposition of Example 2 is more effective than the propan-2-ol standardreference and passes the requirements for EN 1500 for hygienic handrubs.

Example 17: Efficacy of Example 4 as a Handrub

The protocol of Example 16 was repeated for the composition of Example4.

Analysis of the results showed that the reference standard had a MeanLog Reduction Factor of 3.90 and the composition of Example 2 had a MeanLog Reduction Factor of 4.23. The Mean Log Reduction Factor of the testproduct was greater than that of the reference standard, therefore thecomposition of Example 4 is more effective than the reference and passesthe requirements for EN 1500 for hygienic handrubs.

Example 18: Virucidal Quantitative Suspension Test

The composition of Example 2 was tested to evaluate itsvirus-inactivating properties using the Virucidal QuantitativeSuspension Test for Chemical Disinfectants and Antiseptics in accordancewith European Standard BS EN 14476:2005 Chemical Disinfectants andAntiseptics used in Human Medicine (British Standards Institution, 389Chiswick High Road, London).

The virucidal studies were carried out at 80% concentration usingcontact times of 1, 5, 15, 30 and 60 minutes using Rhinovirus (commoncold; ATCC VR-482), Influenza virus (ATCC VR-1741) and Enterovirus 71(hand, foot and mouth disease virus; ATCC VR-1775) as test viruses.

The test virus suspension was prepared according to test standard clause6.3. BGM cells were cultivated with Dulbecco's Modified Eagles Mediumand 10% fetal calf serum. Rhinovirus (common cold), Influenza virus andEnterovirus 71 (hand, foot and mouth disease virus) were added to themonolayer for 1 hour at 37° C. Cells were subjected to a threefoldfreeze/thaw process. Cellular debris was removed by low speedcentrifugation and the supernatant was stored at −80° C. as test virussuspension.

Infectivity was determined from the endpoint according to test standardclause 6.5.1. 0.1 mL of each dilution was transferred into eight wellsof a 96-well microtitre plate, followed by addition of 0.1 mL of freshlytrypsinised BGM cells. Microtitre plates were incubated at 37° C. in a5% CO₂ atmosphere. The cytopathic effect was determined after 7 daysusing an inverted microscope. The estimated virus concentration wascalculated using the Spearman-Kärber method (BS EN 14476 clause 1.1).

Determination of virucidal activity was determined according to teststandard clause 6.6. The sample was examined as an 80% solution in hardwater (clause 5.2.2.2). Contact times were 1, 5, 15, 30 and 60 minutes.The volume of test virus suspension was 0.1 mL, interfering substance(0.1 mL) and test product (0.8 mL). Activity of the disinfectant wasstopped by dilution to 10⁻⁸ immediately at the end of the desiredcontact time. Titration of the virus control was performed at contacttimes of 0 minutes and 60 minutes (clause 6.6.8).

Determination of cytotoxicity was performed according to test standardclause 6.6.4.1 with hard water (200 μL) and test product (800 μL). Cellsensitivity to virus was determined by comparative virus titration oncells in the presence and absence of disinfectant (clause 6.6.4.2 b).Formaldehyde solution (0.7%) was used as a reference standard (clause6.6.7.1). Cytotoxicity of the formaldehyde solution was determinedaccording to test standard clause 6.6.7.2 with dilutions up to 10⁻⁵.Contact times were 5, 15, 30 and 60 minutes.

The composition of Example 2 demonstrated effectiveness as an 80%solution against Rhinovirus, Influenza virus and Enterovirus 71 after acontact time of 60 minutes. The reduction exceeded 4 log₁₀-steps. It isconcluded that the composition of Example 2 is virucidal againstRhinovirus (common cold), Influenza virus and Enterovirus 71 (hand, footand mouth disease virus)

Example 19: Virucidal Quantitative Suspension Test

The protocol of Example 18 was repeated for the composition of Example 4to evaluate its virus-inactivating properties.

The composition of Example 4 was shown to inactivate Rhinovirus,Influenza virus and Enterovirus 71 after a contact time of 60 minutes.The reduction exceeded 4 log₁₀-steps. It is concluded that thecomposition of Example 4 is virucidal against Rhinovirus (common cold),Influenza virus and Enterovirus 71 (hand, foot and mouth disease virus).

Example 20: Activity, Persistent Activity and Cumulative Activity

The composition of Example 2 was tested to evaluate the activity of thetest formulation in reducing the bacterial population of the handsimmediately after a single use and to determine persistent activity(inhibition of growth) after three hours and six hours. Cumulativeactivity measurements were made over a five day period. The compositionwas tested in accordance with the protocol of ASTM E115-11—Standard TestMethod for Evaluation of Surgical Hand Scrub Formulations (ASTMInternational, 100 Barr Harbor Drive, West Conshohocken, Pa., USA).

The immediate activity (log₁₀ reduction) was calculated from the averagebaseline log₁₀ of a volunteer's hand minus the log₁₀ of thepost-treatment count for that hand. The composition of Example 2 showed100% bacterial reduction after using this composition. Persistentactivity was calculated from the variance in log₁₀ reduction after 3, 6and 12 hours glove wear. Results showed that bacterial reduction was100% after three hours (σ² _(3h)=0) and six hours (σ² _(6h)=0). Thebacterial reduction after 12 hours was a minimum of 99.5% (σ²_(12h)=6.25×10⁻⁶).

Cumulative activity results for Day 1 (two applications of composition)and Day 5 (12 applications of composition) both showed 100% bacterialreduction. In conclusion, the composition of Example 2 had an obvioussterilisation effect.

Example 21: Activity, Persistent Activity and Cumulative Activity

The composition of Example 4 was tested in accordance with the protocolof Example 20.

When tested in accordance with ASTM E1115-11, the composition of Example4 showed 100% bacterial reduction after using the formulation.Persistent activity results showed that bacterial reduction was 100%after three hours and six hours. The bacterial reduction after 12 hourswas a minimum of 99.5%. Cumulative activity results showed that Day 1(two applications of composition) and Day 5 (12 applications ofcomposition) both demonstrated 100% bacterial reduction. In conclusion,the composition of Example 4 had an obvious sterilisation effect.

1. A sanitizing composition comprising: i) an alkoxy silyl ammoniumfilm-forming compound; ii) a benzalkonium or benzethonium chloride; iii)a polymeric biguanide; and iv) a surfactant system comprising: a. analcohol ethoxylate; and b. an alkylglucoside or alkylpolyglycoside. 2.The sanitizing composition according to claim 1 wherein the alkoxy silylammonium film-forming compound is selected from3-trimethoxysilylpropyl-N,N-dimethyl-N-octadecyl ammonium chloride,3-triethoxysilylpropyl-N,N-dimethyl-N-octadecyl ammonium chloride,3-triethoxysilylpropyl-N,N-dimethyl-N-isodecyl ammonium chloride and3-trimethoxysilylpropyl-N,N-dimethyl-N-isodecyl ammonium chloride. 3.The sanitizing composition according to claim 1 wherein theconcentration of alkoxy silyl ammonium film-forming compound is 0.1% to1.5% w/w of the composition.
 4. The sanitizing composition according toclaim 1 wherein the benzalkonium or benzethonium chloride is present inan amount of 0.1% to 1.0% w/w of the composition.
 5. The sanitizingcomposition according to claim 1 wherein the polymeric biguanide is apolyaminopropyl biguanide or polyhexamethylene biguanide.
 6. Thesanitizing composition according to claim 1 wherein the polymericbiguanide is present in an amount of 0.1% to 1.5% w/w of thecomposition.
 7. (canceled)
 8. The sanitizing composition according toclaim 1 wherein the alcohol ethoxylate surfactant is present in anamount of 0.1% to 1% w/w of the composition.
 9. (canceled)
 10. Thesanitizing composition according to claim 1 wherein the alkylglucosideor alkylpolyglycoside is present in an amount of 0.1% to 0.5% w/w of thecomposition.
 11. The sanitizing composition according to claim 1 furthercomprising one or more of a rheological modifier, a pH adjustor, alubricant or humectant, a fragrance and a dye.
 12. (canceled) 13.(canceled)
 14. The sanitizing composition according to claim 1 in theform of a liquid.
 15. The sanitizing composition according to claim 1 inthe form of a gel.
 16. The sanitizing composition according to claim 1,wherein said composition contains no alcohol.
 17. A method of sanitizingor disinfecting skin comprising applying to the skin, the sanitizingcomposition of claim
 1. 18. A method according to claim 17 wherein theskin is the skin of hands or feet.
 19. A method of treating orpreventing a fungal infection of the skin, comprising applying thesanitizing composition of claim 1 to the skin of a subject.
 20. A methodaccording to claim 19 wherein the fungal infection is a Tinea infection.21. A method of deodorizing and/or sanitizing the air comprisingatomizing the composition according to claim 14 into the air in anenclosed environment.